Diagnostic and Prognostic Biomarkers in Parkinson Disease (PROBE)
Recruitment status was Active, not recruiting
The overall goal of PROBE is to evaluate the feasibility and potential utility of three markers (alpha-synuclein, transcriptomic profiles and olfactory function) to determine the risk or prognosis of PD.
Multiple System Atrophy
Progressive Supranuclear Palsy
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Blood Alpha-Synuclein, Gene Expression, and Smell Testing as Diagnostic and Prognostic Biomarkers in Parkinson's Disease|
- α-synuclein, transcriptomic profiles and olfactory function [ Time Frame: Three years ] [ Designated as safety issue: No ]
- Unified Parkinson Disease Rating Scale (UPDRS) [ Time Frame: Three Years ] [ Designated as safety issue: No ]
- University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Three Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole Blood, serum
|Study Start Date:||August 2007|
|Estimated Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
PROBE will test three biomarkers in PD subjects and controls to determine their feasibility and potential utility as markers of risk and prognosis for PD. This is a case control study, in which PD subjects will be compared to neurologically healthy controls and disease controls (MSA and PSP). The blood biomarker samples will be drawn once to evaluate blood alpha-synuclein levels as well as collection of lymphocyte mass for array analysis. Olfaction will be measured using the UPSIT for all subjects. The UPSIT will be conducted as part of PostCEPT for PD subjects and will only be repeated in this study for PD subjects in not done within 6 months. Control subjects may also choose to submit a blood specimen for processing and storage at the Coriell Institute for Medical Research, a research resource supported by the NINDS Human Genetics Resource Center.
Follow-up of the PD population over a 3-year period will allow us to evaluate the prognosis for important motor aspects of PD that will occur frequently in this cohort. These complications of PD include motor complications, postural instability, and non-motor impairment such as cognitive decline.
Healthy and disease control subjects may give permission at the Baseline visit to be contacted and followed in the previously established PSG FOUND study using mail and telephone contact to assess clinical status. Participation in the FOUND study provides another mechanism to maintain contact with subjects and collect supplemental data beyond that collected at the PROBE Baseline visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653783
|United States, New York|
|Parkinson Study Group|
|Rochester, New York, United States|
|Principal Investigator:||Bernard Ravina, MD||University of Rochester|